Oral Biologics And Biosimilars Market

• In March 2022, Amneal Pharmaceuticals, Inc. announced that the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen, had been approved by the U.S. Food and Drug Administration (FDA). The product will be sold under the brand name RELEUKO.

• In December 2021, Gedeon Richter, Hungary's largest drug maker, reached an agreement with Hikma Pharmaceuticals, a London-listed drug maker, to out-license biosimilars denosumab for commercialization in the U.S.

In this report, The Oral Biologics & Biosimilars Market has been segmented by Therapy, Disease, Molecule Type, Distribution Channel and Geography.

Oral Biologics & Biosimilars Market, Segmentation by Therapy

The Oral Biologics & Biosimilars Market has been segmented by Therapy into Lymphocyte Modulators, Interleukin Inhibitors and Tumor Necrosis Factor-Alpha Inhibitors.

Lymphocyte Modulators

Lymphocyte modulators hold nearly 40% of the oral biologics & biosimilars market, driven by their effectiveness in treating autoimmune disorders such as multiple sclerosis. Growing R&D investments and an expanding patient pool are fueling demand in this segment.

Interleukin Inhibitors

Interleukin inhibitors account for about 35% of the market, with significant adoption in the management of chronic inflammatory diseases. The rising prevalence of conditions like psoriasis and rheumatoid arthritis supports strong growth in this category.

Tumor Necrosis Factor-Alpha Inhibitors

Tumor Necrosis Factor-Alpha (TNF-α) inhibitors represent around 25% of the market share, widely used in the treatment of autoimmune and inflammatory disorders. Increased preference for targeted therapies and biosimilars is boosting uptake in this segment.

Oral Biologics & Biosimilars Market, Segmentation by Disease

The Oral Biologics & Biosimilars Market has been segmented by Disease into Asthma, Crohn`S Disease, Carcinoma, Arthritis, Diabetes, Multiple Myeloma, Enterocolitis, Multiple Sclerosis, Sarcoma and Psoriasis and Others.

Asthma

Asthma treatments in the oral biologics & biosimilars market account for approximately 12% of the share, driven by the growing prevalence of chronic respiratory conditions worldwide. Advancements in targeted biologic therapies are improving patient outcomes and boosting adoption.

Crohn's Disease

Crohn's disease represents nearly 10% of the market, with oral biologics offering effective management of inflammatory bowel conditions. Increasing diagnosis rates and awareness are contributing to steady segment growth.

Carcinoma

Carcinoma treatments make up about 8% of the market, supported by advancements in targeted oncology therapies. The rise in global cancer incidence is fueling demand for innovative biologics and biosimilars.

Arthritis

Arthritis accounts for around 15% of the market, with biologics proving highly effective in reducing inflammation and slowing disease progression. The aging population and higher disease prevalence are key growth drivers.

Diabetes

Diabetes represents roughly 9% of the market, driven by the need for advanced glucose control therapies. Biologic innovations are enhancing treatment effectiveness and patient compliance.

Multiple Myeloma

Multiple myeloma holds nearly 7% of the market share, with oral biologics offering targeted approaches to cancer treatment. Rising research investments are expanding therapeutic Bin this space.

Enterocolitis

Enterocolitis treatments contribute about 6% to the market, as biologics provide relief from inflammatory gastrointestinal disorders. Increasing incidence and demand for effective long-term therapies are driving growth.

Multiple Sclerosis

Multiple sclerosis accounts for close to 11% of the market, with biologics improving neurological outcomes and slowing disease progression. Growing access to advanced therapies is boosting market penetration.

Sarcoma and Psoriasis

Sarcoma and psoriasis combined represent nearly 14% of the market, benefiting from targeted biologics that address rare cancers and chronic skin conditions. Increasing awareness and diagnosis rates are propelling demand.

Others

The others category makes up around 8% of the market, including treatments for less common but significant conditions. Expanding biologic and biosimilar pipelines are expected to broaden therapeutic coverage in this segment.

Oral Biologics & Biosimilars Market, Segmentation by Molecule Type

The Oral Biologics & Biosimilars Market has been segmented by Molecule Type into Vaccines, Proteins & Peptides, Monoclonal Antibodies and Other Molecule Types.

Vaccines

Vaccines hold approximately 28% of the oral biologics & biosimilars market, driven by rising demand for preventive healthcare solutions and advancements in oral vaccine delivery technologies. Increasing immunization programs and global health initiatives are further fueling growth.

Proteins & Peptides

Proteins & peptides account for nearly 25% of the market, offering targeted treatment options for chronic and rare diseases. Their improved stability and bioavailability in oral formulations are accelerating adoption.

Monoclonal Antibodies

Monoclonal antibodies represent about 32% of the market share, benefiting from their high specificity in treating autoimmune disorders and oncological conditions. The shift toward patient-friendly oral versions is expected to strengthen this segment further.

Other Molecule Types

The other molecule types category holds around 15% of the market, encompassing innovative biologic formats under research and development. Continuous breakthroughs in biopharmaceutical technology are expanding therapeutic potential in this space.

Oral Biologics & Biosimilars Market, Segmentation by Distribution Channel

The Oral Biologics & Biosimilars Market has been segmented by Distribution Channel into Hospital Pharmacies, Retail Pharmacies and Online Pharmacies.

Hospital Pharmacies

Hospital pharmacies command approximately 45% of the oral biologics & biosimilars market, driven by the need for specialized handling and controlled dispensing of high-value therapies. Their direct link to critical care services ensures patient access to complex biologic treatments.

Retail Pharmacies

Retail pharmacies hold nearly 35% of the market share, offering widespread accessibility and convenience for patients managing chronic conditions. Their role in providing patient counseling and routine prescriptions supports steady demand in this segment.

Online Pharmacies

Online pharmacies account for around 20% of the market, benefiting from digital healthcare adoption and the rising preference for home delivery services. Their ability to offer competitive pricing and discreet purchasing options is fueling growth.

Oral Biologics & Biosimilars Market, Segmentation by Geography

In this report, The Oral Biologics & Biosimilars Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Oral Biologics & Biosimilars Market Share (%), by Geographical Region

North America

North America holds a dominant share of around 40% in the oral biologics & biosimilars market, supported by advanced healthcare infrastructure, strong R&D capabilities, and favorable regulatory frameworks that accelerate new product adoption.

Europe

Europe accounts for nearly 30% of the market, driven by robust healthcare systems, high biologics acceptance, and government initiatives promoting the use of cost-effective biosimilars across various therapeutic areas.

Asia Pacific

Asia Pacific captures approximately 20% of the market, with rapid growth fueled by rising healthcare investments, expanding patient base, and increased focus on affordable treatment options in emerging economies.

Middle East & Africa

Middle East & Africa represent about 6% of the market, with expansion supported by improving healthcare access, government-backed pharmaceutical development, and the adoption of advanced therapies.

Latin America

Latin America holds nearly 4% market share, driven by growing demand for specialized treatments and increasing awareness of the benefits of biosimilars in improving patient outcomes.